StrokeNCT05807230
Three-level Network Rehabilitation Model
A study testing Three-level network rehabilitation services within the medical alliance in people with Stroke and Primary Medical Care, run by The First People's Hospital of Huzhou at 1 site in China.
Trial summary
The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Primary Medical Care
- What is being tested?
- Three-level network rehabilitation services within the medical alliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
- confirmed by imaging MRI or CT;
- hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.
Who cannot join
- Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
- patients with lumbar spine or sacral spinal stenosis in the past;
- patients with previous epilepsy;
- patients with previous history of stroke;
- patients with heart and renal failure;
- Patients who cannot cooperate with treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke Rehabilitation System of Oriental and Western Medicine Based on Three-level Network Rehabilitation Model Under the Background of Medical Alliance in Huzhou
The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.
Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.
- Conditions
- Stroke, Primary Medical Care
- Being tested
- Three-level network rehabilitation services within the medical alliance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-level network rehabilitation services within the medical allianceBehavioural
Data of all levels of medical and health institutions in Huzhou region are shared, and advanced rehabilitation technologies are passed down from senior hospitals to grassroots medical institutions. Grassroots medical institutions to patients home for 3 months of rehabilitation training.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy: three-level rehabilitation treatment, Chinese medicine and acupuncture | No intervention | Patients received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment. |
| Conventional therapy and three-level network rehabilitation services | Experimental | Three months after received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment, patients continued to receive three-level network rehabilitation services within the medical alliance. Receives: Behavioral: Three-level network rehabilitation services within the medical alliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer motor score
This scale evaluates the patient's motor ability, including 7 major items and 17 sub-items such as reflex activity, cooperative movement, coordination ability, speed, etc. each item is 0-2 points, a total of 34 points, the higher the score, the better the exercise ability.
Measured: Assessment was made after 3 months of intervention
The Berg balance scale
This scale evaluate the balance ability of the patients, and the balance ability of the two groups of patients before and after 6 months of treatment was scored, including standing, sitting, standing-to-sit transfer, bed-chair transfer, and turning around, totaling 14 items, totaling 56 score (the higher the score, the better the balance ability)
Measured: Assessment was made after 3 months of intervention
National Institute of Health stroke scale
This scale evaluate the neurological function of the two groups before treatment and 4 weeks after treatment, including consciousness, eye movement, visual field, facial paralysis, limb movement, limb coordination, sensation, vision, hearing and touch, totaling 11 items, totaling 42 points (the higher the score, the more serious the neurological deficit of the patient).
Measured: Assessment was made after 3 months of intervention
Barthel index
This scale evaluate the daily living ability of the two groups of patients before treatment and 4 weeks after treatment, including eating, bathing, grooming, dressing, control of urination, toileting, and seat transfer.10 items such as walking and going up and down stairs, each item is scored from 0 to 10,with a total of 100 points (the higher the score, the stronger the patient's daily living ability).
Measured: Assessment was made after 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Huzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenming Feng, The First People's Hospital of Huzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05807230
- Sponsor's protocol ID
- Wenming Feng
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Rehabilitation System of Oriental and Western Medicine Based on Three-level Network Rehabilitation Model Under the Background of Medical Alliance in Huzhou
- ClinicalTrials.gov ID
- NCT05807230
- Acronym / sponsor ID
- Wenming Feng
- Conditions
- Stroke, Primary Medical Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The First People's Hospital of HuzhouUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical trial was to compare the effects of different interventions on the recovery of stroke patients. The main question it aims to answer are: whether the intervention mode of integrated Chinese and western medicine is more valuable to implement.
Researchers randomly assigned 90 patients to either group A or Group B, 45 in each group. Group A adopted the conventional three-level rehabilitation model; Group B adopted the three-level network rehabilitation model under the medical alliance for rehabilitation treatment with combination of Chinese and Western medicine. Fugl-Meyer motor score was used to assess the patient's motor ability, Berg balance scale was used to assess the patient's balance ability, National Institute of Health stroke scale was used to assess the patient's neurological function, and modified Barthel index was used to assess the patient's ability of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy: three-level rehabilitation treatment, Chinese medicine and acupuncture | No intervention | –Patients received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment. |
| Conventional therapy and three-level network rehabilitation services | Experimental | Behavioral: Three-level network rehabilitation services within the medical allianceThree months after received conventional three-level rehabilitation treatment, conventional Chinese medicine and acupuncture treatment, patients continued to receive three-level network rehabilitation services within the medical alliance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients whose primary disease is stroke, whose diagnosis conforms to the "Chinese and Western Medicine Emergency Diagnosis and Treatment Expert Consensus for Acute Ischemic Stroke";
- confirmed by imaging MRI or CT;
- hemiplegia symptoms; clear-headed, able to actively cooperate with the doctor's treatment, the basic vital signs are stable, and the neurological signs basically do not develop.
Key exclusion criteria (6 listed)
- Patients with lower extremity joint disease, osteoarthritis or ankle joint injury in the past;
- patients with lumbar spine or sacral spinal stenosis in the past;
- patients with previous epilepsy;
- patients with previous history of stroke;
- patients with heart and renal failure;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-level network rehabilitation services within the medical allianceData of all levels of medical and health institutions in Huzhou region are shared, and advanced rehabilitation technologies are passed down from senior hospitals to grassroots medical institutions. Grassroots medical institutions to patients home for 3 months of rehabilitation training. | Behavioural | Conventional therapy and three-level network rehabilitation services |
Primary outcome
Fugl-Meyer motor score
Time frame: Assessment was made after 3 months of intervention
This scale evaluates the patient's motor ability, including 7 major items and 17 sub-items such as reflex activity, cooperative movement, coordination ability, speed, etc. each item is 0-2 points, a total of 34 points, the higher the score, the better the exercise ability.
The Berg balance scale
Time frame: Assessment was made after 3 months of intervention
This scale evaluate the balance ability of the patients, and the balance ability of the two groups of patients before and after 6 months of treatment was scored, including standing, sitting, standing-to-sit transfer, bed-chair transfer, and turning around, totaling 14 items, totaling 56 score (the higher the score, the better the balance ability)
National Institute of Health stroke scale
Time frame: Assessment was made after 3 months of intervention
This scale evaluate the neurological function of the two groups before treatment and 4 weeks after treatment, including consciousness, eye movement, visual field, facial paralysis, limb movement, limb coordination, sensation, vision, hearing and touch, totaling 11 items, totaling 42 points (the higher the score, the more serious the neurological deficit of the patient).
Barthel index
Time frame: Assessment was made after 3 months of intervention
This scale evaluate the daily living ability of the two groups of patients before treatment and 4 weeks after treatment, including eating, bathing, grooming, dressing, control of urination, toileting, and seat transfer.10 items such as walking and going up and down stairs, each item is scored from 0 to 10,with a total of 100 points (the higher the score, the stronger the patient's daily living ability).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-level network rehabilitation services within the medical alliance in people with Stroke and Primary Medical Care, run by The First People's Hospital of Huzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer motor score (time frame: Assessment was made after 3 months of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.